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临床试验/NCT02713958
NCT02713958Unknown不适用

The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Range of motion

研究概览

简要总结

This experimental research aims to examine the efficacy of Telerehabilitation treatment using a computerized system (MediTouch) in improving the upper limb function post elbow fractures. 24 participants aged 18-80 who are post surgery to fixate elbow fractures or arthrolysis of the elbow will be invited to participate in the study. The subjects will be matched into two groups according to age and fracture type to study and control groups. Both groups will be treated for a month in ambulatory clinic in the hospital and will do self-practice at home according to a intervention protocol. The subjects in the experimental group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly, and the subjects in the control group will receive three treatments in the clinic every week. Activity daily living (ADL), Range of Motion, Hand strength disability and pain will be assessed before and after the intervention in order to asse the efficacy of the intervention.

详细描述

The elbow joint has an important role in the upper limb function. The rehabilitation process after injury is complex as a result of the common complications of the elbow after trauma, as stiffness, restriction in range of motion and occurrence of Heterotopic Ossification. According to the literature, early active mobilization reduces the incidence of these complications. Yet, current treatment protocols are based mainly on clinical experience and there is a lack in evidence-based trials regarding their efficiency. Recently, Occupational Therapists include Telerehabilitation in their treatments, using advanced technologies, which can be adapted to orthopedic injuries. The reported advantages of Telerehabilitation are the option to do self-practice without the need of arriving at a medical center and greater motivation to practice. This experimental research will examine the efficacy of Telerehabilitation treatment using a computerized system (MediTouch) in improving the upper limb function post elbow fractures.

This research will include 24 participants aged 18-80, from the hand surgery unit in Sheba medical center, who are post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize. Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves will be excluded. The subjects will be matched into two groups according to age and fracture type to study and control groups. Both groups will be treated for a month in ambulatory clinic in the hospital and will do self-practice at home. The subjects in the study group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly, and the subjects in the control group will receive three treatments in the clinic every week. All subjects will be assessed before and after the intervention for hand function in everyday activities using The Jebsen-Taylor Hand Function Test, for disability and symptoms due to the injury using The Disabilities of the arm, shoulder and hand questionnaire, for pain and disability after injury in the elbow using The Patient-Rated Elbow Evaluation, for range of motion using Goniometer and for strength using Dynamometer. The Participants in the study group will also fill out questionnaires to evaluate level of satisfaction from the treatment and of the system usability. The hypotheses will be tested by the differences between groups in range of motion, function and satisfaction measures in order to assess the efficacy of the treatment in Telerehabilitation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize

排除标准

  • •Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves

研究组 & 干预措施

Tele rehabilitation

Experimental

Telerehabilitation:The subjects in the study group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly . At home they will be asked practice daily active exercises with the Meditouch Ltd. system.

干预措施: Telerehabilitation (Other)

rehabilitation

Active Comparator

Traditional Occupational Therapy:The subjects in this group will receive three treatments in the clinic every week. At home they will be asked to practice daily active exercises in the same level of difficulty and duration as the study group but without the Meditouch Ltd. system

干预措施: Rehabilitation (Other)

结局指标

主要结局

Range of motion

时间窗: Change of range of motion in degrees from baseline up to 6 weeks

次要结局

  • The Patient-Rated Elbow Evaluation (PREE)(Change of PREE score from baseline up to 6 weeks)
  • Jebsen and Taylor functional test(Change of Jebsen score from baseline up to 6 weeks)
  • The Disabilities of the arm, shoulder and hand questionnaire (Dash),(Change of Dash score from baseline up to 6 weeks)
  • Grip force(Change of grip force in kg from baseline up to 6 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yafi Levanon PhD

Deputy of Occupational Therapy department

Sheba Medical Center

研究点 (1)

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